VeriStrat® Test Results Correlate with Survival Outcomes in Advanced Lung Cancer

April 23rd, 2012

Boulder, Colorado – April 20, 2012 –   Results from the combined analysis of two European Phase II trials were presented today at the 3rd European Lung Cancer Conference in Geneva, Switzerland.    The VeriStrat retrospective analysis was performed on serum samples from advanced non-squamous non-small cell lung cancer (NSCLC) patients treated with the combination therapy bevacizumab plus erlotinib.  Results showed that the VeriStrat test was able to identify patients likely to have better and worse survival outcomes when treated with the combination therapy.    

Pretreatment serum samples from 114 patients treated with bevacizumab plus erlotinib were classified as either VeriStrat Good or VeriStrat Poor.  The study showed there was a statistically significant difference in overall survival between the two groups.  Patients classified as VeriStrat Good had a median overall survival of 13.4 months versus 6.2 months for patients classified as VeriStrat Poor (p=0.0027, HR=0.480, 95%CI:0.294-0.784).  Median progression free survival for patients classified as VeriStrat Good was 4.0 months and 3.2 month for patients classified as VeriStrat Poor, but this difference was not statistically significant (p=0.2632, HR=0.768, 95% CI: 0.482-1.223).

Researchers concluded that the VeriStrat test may be useful for clinical decision-making, representing a prognostic and potentially predictive biomarker for treatment with erlotinib and erlotinib combinations.  Prospective trials are ongoing, including a Phase III trial in advanced squamous cell lung cancer, sponsored by the European Thoracic Oncology Platform (ETOP). 

“These data represent the third study in which we have shown that VeriStrat classification correlates with survival outcomes in lung cancer patients treated with bevacizumab plus erlotinib, “ commented David Brunel, CEO of Biodesix. “Although additional data is needed, this study supports the view that VeriStrat may be useful in identifying lung cancer patients that could benefit from the combination of bevacizumab and erlotinib, which is regarded as less toxic than traditional chemotherapy.”

About VeriStrat:  VeriStrat is a serum proteomic test currently available for patients with advanced NSCLC.  The test identifies patients who are likely to have good or poor outcomes after treatment with epidermal growth factor receptor inhibitors (EGFRIs).  Samples are processed in Biodesix’ CLIA certified laboratory and results are typically reported within 72 hours of sample shipment.  VeriStrat has been validated in clinical studies with over 1500 patients.  For more information on VeriStrat or to order VeriStrat, visit www.VeriStratSupport.com or call the VeriStrat Support Hotline at 1-866-432-5930.

About Biodesix:  Biodesix is a personalized medicine company focused on the development of diagnostic products that inform treatment decisions and improve patient care.  The Company’s goal is to give physicians more information about the patient and their disease; understanding the clinically meaningful information contained within each patient’s molecular profile leads to better care and better outcomes. The Company’s unique approach is based on ProTS®, proprietary technology which exploits the power of mass spectrometry and enables the discovery of specific molecular profiles. Biodesix collaborates with clinical investigators to address critical clinical questions, and partners with biotechnology and pharmaceutical companies to develop diagnostics to select patients most likely to benefit from novel therapies. For more information about Biodesix, please visit www.Biodesix.com.

This press release contains statements that are hereby identified as “forward-looking statements” for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the Company’s inability to further identify, develop and achieve commercial success for products and technologies; the risk that the Company’s financial resources will be insufficient to meet the Company’s business objectives; uncertainties relating to the regulatory approval process and changes in relationships with strategic partners. We disclaim any intent or obligation to update these forward-looking statements.

Biodesix Announces Phase 3 Clinical Trial Collaboration with Kadmon

February 27th, 2012

Boulder, Co. – February 27, 2012 – Biodesix Inc., a fully integrated molecular diagnostic company dedicated to personalizing medicine, today announced a collaboration with Kadmon Corporation, LLC, to explore the utility of Biodesix’ VeriStrat® test in a Phase 3 non-small cell lung cancer (NSCLC) study of Kadmon’s KD019, a reversible tyrosine kinase inhibitor (TKI) targeting EGFR, HER2, VEGFR2 & 3, and SRC.

The Phase 3 study is designed to evaluate KD019 compared to erlotinib in patients with stage IIIB/IV NSCLC who have progressed after first- or second-line chemotherapy.  It incorporates an exploratory analysis using VeriStrat, a commercially available, blood-based test that is currently used to help physicians guide treatment for patients with non-small cell lung cancer. VeriStrat testing will be performed on serum samples from the study to assess the test’s utility in identifying patients with better or worse outcomes following treatment with KD019.  As a multiple TKI with superior potency against wild-type EGFR, KD019 is designed to improve overall survival compared to erlotinib.

 “We are very pleased to work with Kadmon on this program” commented Paul Beresford, Ph.D., Biodesix’ Vice President of Business Development and Strategic Marketing.  “Our successful collaboration may bring a personalized approach to this exciting new therapy.”  Over the past year Biodesix has forged multiple partnerships with bio-pharmaceutical companies to examine VeriStrat’s utility with innovative oncology therapies and to discover novel diagnostic tests.   

John Ryan, Ph.D., M.D., Chief Medical Officer of Kadmon said, “This collaboration is aligned with our strategic vision to advance leading-edge science and therapies targeting multiple pathways of proliferation and survival in disease.”

For more information about the Phase 3 study of KD019, visit www.clinicaltrials.gov.


About VeriStrat

VeriStrat is a serum proteomic test that helps physicians guide treatment decisions for patients with advanced non-small cell lung cancer (NSCLC). The test identifies patients who are likely to have good or poor outcomes after treatment with epidermal growth factor receptor inhibitors. Samples are processed in Biodesix’ CLIA certified laboratory and results are typically reported within 72 hours of sample shipment. VeriStrat has been validated in clinical studies with over 2500 patients. For more information or to order VeriStrat, visit www.VeriStratSupport.com .

About Biodesix

Biodesix is a personalized medicine company focused on the development of diagnostic products that inform treatment decisions and improve patient care.  The Company’s goal is to give physicians more information about the patient and their disease; understanding the clinically meaningful information contained within each patient’s molecular profile leads to better care and better outcomes. The Company’s unique approach is based on ProTS®, proprietary technology which exploits the power of mass spectrometry and enables the discovery of specific molecular profiles. Biodesix collaborates with clinical investigators to address critical clinical questions, and partners with biotechnology and pharmaceutical companies to develop diagnostics to select patients most likely to benefit from novel therapies. For more information about Biodesix, please visit www.Biodesix.com.

Biodesix Relocates to Boulder, CO

February 22nd, 2012

BOULDER, CO — Biodesix, Inc., a fully integrated molecular diagnostics company dedicated to personalizing medicine, today announced the relocation of their corporate headquarters from Broomfield, Colorado to Boulder, Colorado. The new location at 2970 Wilderness Place, Suite 100, Boulder, CO 80301 will be able to accommodate Company’s future growth. Biodesix Research & Development locations, as well as the Company’s CLIA certified laboratory will remain at their current locations.

Biodesix Receives New EU and US Patents for Blood-based Oncology Tests

January 30th, 2012

BROOMFIELD, CO —January  9, 2012–Biodesix, Inc., a fully integrated molecular diagnostics company dedicated to personalizing medicine, today announced the issuance of three additional patents.  The U.S. Patent & Trademark Office (PTO) granted two new patents which provide intellectual property protection for methods relating to the Company’s products and technology. In addition, the European Patent Office granted to Biodesix a patent providing coverage for the Company’s product VeriStrat®, for the selection of patients for drug therapy. VeriStrat is a serum proteomic test currently available in the United States to help physicians guide therapy for patients with advanced lung cancer.

European patent number 2,247,954 is the counterpart to U.S. patent number 7,867,775 and covers the use of VeriStrat for selection of head and neck cancer patients for treatment with targeted drugs. U. S. patent number 8,024,282 (‘282) provides additional intellectual property protection for the methods used with VeriStrat which are also related to Biodesix’ underlying core ProTS® technology.  Specifically, the ‘282 patent supports the Company’s methods for the reliable and reproducible classification of samples in clinical diagnostics using computer systems configured as probabilistic classifiers.  Related U.S. patent 7,906,342 covers Biodesix’ methods for using mass spectrometry of patient samples to monitor cancer patients being treated with drugs targeting the epidermal growth factor receptor (EGFR) pathway for response or non-responsiveness to the treatment.  Biodesix also received notice from the PTO that two additional patent applications covering the use of VeriStrat for monitoring of head and neck, as well as colorectal cancer patients being treated with drugs targeting the EGFR pathway have been allowed; these patents are expected to issue early in the first quarter of 2012.

Drug therapies targeting the EGFR pathway and related molecular targets play an increasingly important role in cancer therapy.  Identifying patients likely to benefit from this class of drugs is key to improving overall patient outcomes.

“The expansion of our patent estate is an integral part of our global strategy to protect VeriStrat and our technology platform,” commented David Brunel, Biodesix CEO.  “This protection strengthens our commercial position as a leading provider of diagnostics to personalize medicine for oncology patients.”

About Biodesix

Biodesix is a fully integrated molecular diagnostics company advancing the development of products for personalized medicine. Biodesix provides physicians with tools for earlier disease detection, more accurate diagnosis, and better therapeutic guidance. In 2009, Biodesix launched VeriStrat®, a serum proteomic test that helps physicians guide treatment for patients with non-small cell lung cancer. VeriStrat is based on ProTS®, proprietary technology which harnesses the power of mass spectrometry and enables the discovery of specific molecular profiles that characterize a patient’s condition or likely outcome in response to therapy.  The ProTS® platform has broad application and provides the foundation for collaborations with leading researchers as well as partnerships with biotechnology and pharmaceutical companies seeking to develop companion diagnostics and improve the targeting of their therapies. For more information about Biodesix, please visit the Company’s website at www.Biodesix.com.

Media Contacts:

Erik Clausen or Kena Hudson

Chempetitive Group for Biodesix

biodesix@chempetitive.com

(510) 908-0966

Protein Test Found to Boost NSCLC Survival, Costs (MedPage Today)

January 16th, 2012

By Charles Bankhead, Staff Writer, MedPage Today

This study found that choosing second-line therapy on the basis of a protein-expression test modestly improved survival in patients with advanced non-small cell lung cancer (NSCLC). The four- to six-week survival advantage held up in a sensitivity analysis involving 10,000 simulations. Choosing second-line therapy on the basis of a protein-expression test modestly improved survival in patients with advanced non-small cell lung cancer (NSCLC), computer modeling suggested.

Use of the test to decide whether to give a patient an epidermal growth factor receptor (EGFR) inhibitor led to a predicted survival of 10 months versus eight to nine months with three conventional decision-making strategies.  Read more at MedPage Today.